Serpentine coiled ladder stent

ABSTRACT

A serpentine coiled ladder stent is provided, in which the coil is formed from a wound strip of cells, wherein the sides of the cells are serpentine. Thus, the stent is comprised of a strip helically wound into a series of coiled windings, wherein the strip is formed of at least two side bands connected to each other, for example by a series of cross struts. Each side band is formed in a serpentine pattern comprising a series of bends, wherein upon expansion of the stent, the bends of the side bands open to increase the length of each of the individual cells in the helical direction, thereby lengthening the strip in the helical direction to allow the stent to expand without any significant unwinding of the strip.

FIELD OF THE INVENTION

The invention relates generally to stents, which are endoprosthesesimplanted into vessels within the body, such as blood vessels, tosupport and hold open the vessels, or to secure and support otherendoprostheses in the vessels.

BACKGROUND OF THE INVENTION

Various stents are known in the art. Typically stents are generallytubular in shape, and are expandable from a relatively small, unexpandeddiameter to a larger, expanded diameter. For implantation, the stent istypically mounted on the end of a catheter, with the stent being held onthe catheter at its relatively small, unexpanded diameter. By thecatheter, the unexpanded stent is directed through the lumen to theintended implantation site. Once the stent is at the intendedimplantation site, it is expanded, typically either by an internalforce, for example by inflating a balloon on the inside of the stent, orby allowing the stent to self-expand, for example by removing a sleevefrom around a self-expanding stent, allowing the stent to expandoutwardly. In either case, the expanded stent resists the tendency ofthe vessel to narrow, thereby maintaining the vessel's patency.

Some examples of patents relating to stents include U.S. Pat. No.4,553,545 to Maass et al.; U.S. Pat. No. 4,733,665 to Palmaz; U.S. Pat.Nos. 4,800,882 and 5,282,824 to Gianturco; U.S. Pat. Nos. 4,856,516,4,913,141, 5,116,365 and 5,135,536 to Hillstead; U.S. Pat. Nos.4,649,922, 4,886,062, 4,969,458 and 5,133,732 to Wiktor; U.S. Pat. No.5,019,090 to Pinchuk; U.S. Pat. No. 5,102,417 to Palmaz and Schatz; U.S.Pat. No. 5,104,404 to Wolff; U.S. Pat. No. 5,161,547 to Tower; U.S. Pat.No. 5,383,892 to Cardon et al.; U.S. Pat. No. 5,449,373 to Pinchasik etal.; and U.S. Pat. No. 5,733,303 to Israel et al.

U.S. Pat. No. 4,553,545 to Maass et al. (the “Maass '545 patent”), thedisclosure of which is hereby expressly incorporated by reference intothis application, shows various stents in the form of coiled springs.FIGS. 1 through 7 of that patent illustrate coiled spring stents formedof helically wound wire wherein the diameters of the stents arecontracted and expanded by rotating the spring ends. Such coiled springstents are very flexible, such that they can be tracked easily downtortuous lumens and such that they conform relatively closely to thecompliance of the vessel after deployment. However, while these stentsare very flexible, they also lend relatively unstable support afterexpansion. The individual windings of the coil may move relative to eachother, causing sometimes significant gaps between adjacent windings,which could cause significant portions of the vessel wall to be leftunsupported. Also, the windings of the coil may bend or tilt somewhat,potentially obstructing and seriously compromising the lumen. FIG. 10 ofthe Maass '545 patent illustrates an example of tilted windings in thesecoiled spring stents.

The Maass '545 patent discloses various mechanisms designed to addressthe instability of these coiled spring stents. For example, FIGS. 11through 14 show the use of rigidifying devices in the form of axialsupport members that extend along a side of the stent and maintain therelative positioning of the windings. FIG. 22 shows a stent constructedof a coiled band, wherein the band has openings in it so that it takesthe shape of a ladder. FIG. 23 shows another coiled ladder stent,wherein the ladder is formed by two wires attached to each other bytransverse elements. Each of these coiled ladder stents providesimproved stability when compared to the single strand coiled springstents.

Despite these modifications, one problem with each of the coiled springand coiled ladder stents disclosed in the Maass '545 patent is thatexpansion of the stent results in an unwinding of the coil. Thisunwinding causes twisting of the stent, including rotation of the stentends, which is potentially harmful to the vessel wall. In addition, theexpansion and twisting causes the number of individual windings tolessen, resulting in less windings to support the vessel wall. Thereduction in windings also means either that the length of the stentwill foreshorten significantly, in order to maintain the spacing of thewindings, or that the spacing between the windings will increasesignificantly, in order to maintain the length of the stent, or in someinstances a combination of both. The foreshortening results in lesslengthwise coverage of the vessel wall in the deployed stent as well aslateral movement during deployment which may be harmful to the vesselwall. The increase in the spacing between windings could result insignificant portions of the vessel wall being left unsupported. Both arepotential disadvantages of the coiled spring and coiled ladder stentsdisclosed in the Maass '545 patent.

U.S. Pat. Nos. 4,886,062 and 5,133,732 to Wiktor (the “Wiktor '062patent” and the “Wiktor '732 patent”), the disclosures of which arehereby expressly incorporated by reference into this application, showstents formed of wire wherein the wire is initially formed into a bandof zig-zags forming a serpentine pattern, and then the zig-zag band iscoiled into a helical stent. The stents are expanded by an internalforce, for example by inflating a balloon. Another example of a similarcoiled zig-zag stent is the Crossflex stent marketed by CordisCorporation.

The coiled zig-zag stents that are illustrated in FIGS. 1 through 6 ofthe Wiktor '062 and '732 patents are very flexible, but, again, they arerelatively unstable. The Wiktor '732 patent discloses alternativeconstructions of these coiled zig-zag stents to address theirinstability. In one example, illustrated in FIG. 7 of that patent, astraight longitudinal wire extends along a side of the stent and isconnected to the windings to fix them relative to each other. In anotherexample, illustrated in FIG. 8 of that patent, in various locationsaround the helix of the stent, a bend in the zig-zag wire is made longerthan other bends, so that it can reach and hook around a bend in anadjacent winding of the helix. Each of these constructions results inincreased stability of the stent, but each also results in somereduction in the flexibility of the stent.

SUMMARY OF THE INVENTION

An object of the invention is to provide a stent that is longitudinallyflexible such that it can easily be tracked down tortuous lumens anddoes not significantly change the compliance of the vessel afterdeployment, wherein the stent is relatively stable so that it avoidsbending or tilting in a manner that would potentially obstruct the lumenand so that it avoids leaving significant portions of the vessel wallunsupported.

Another object of the present invention is to provide a stent that haslittle or no twisting or rotation of its ends upon expansion, and thatalso undergoes little or no foreshortening upon expansion andsimultaneously does not result in significant gaps being created betweenadjacent windings of the stent upon expansion.

In accordance with one embodiment of the invention, a stent isconfigured as a coiled stent in which the coil is formed from a woundstrip of cells, wherein the sides of the cells are serpentine. Thus, thestent is comprised of a strip helically wound into a series of coiledwindings, wherein the strip is formed of at least two side bandsconnected to each other, for example by a series of cross struts. Eachside band is formed in a serpentine pattern comprising a series ofbends, wherein upon expansion of the stent, the bends of the side bandsopen to increase the length of each of the individual cells in thehelical direction, thereby lengthening the strip in the helicaldirection to allow the stent to expand without any significant unwindingof the strip.

A serpentine coiled ladder stent according to the invention retains theflexibility associated with coiled spring stents, yet has windings whichare relatively stable and insusceptible to displacement or tilt. Aserpentine coiled ladder stent according to the invention thus providescontinuous support of the vessel tissue without disadvantageouslyobstructing the lumen.

In addition, the serpentine coiled ladder stent substantially avoids theproblems of twisting, end rotation, foreshortening and the creation ofsignificant gaps upon expansion. When the serpentine coiled ladder stentis expanded, the outward radial force on the stent causes the bends inthe serpentine sides to open up and become straighter, thereby causingthe overall length of the strip in the helical direction to increase. Byproviding a serpentine strip that allows the strip itself to lengthen inthe helical direction as the stent is expanded, the increase in thediameter of the stent is accommodated by a lengthening of the strip,rather than by an unwinding of the strip. Thus, the number of windingsmay be maintained, and rotation of the ends and foreshortening or theopening of gaps between windings can be substantially reduced oravoided. In fact, the serpentine coiled ladder stent may be constructedso that adjacent points on adjacent windings remain adjacent to eachother as the stent is expanded. Thus, the two ends of the strip at theends of the stent may be joined, for example by welding, to therespective adjacent windings, thereby creating smooth ends and assuringno relative rotation.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic diagram of three coiled wire stents as in theprior art, the first having equally spaced windings, the second havingunevenly spaced windings, and the third have some tilted windings;

FIG. 2 shows a coiled ribbon stent in an unexpanded condition;

FIG. 3 shows the coiled ribbon stent of FIG. 2 in an expanded condition;

FIG. 4 shows a prior art coiled ladder stent, similar to those shown anddescribed in U.S. Pat. No. 4,553,545 to Maass et al.;

FIG. 5 shows a serpentine coiled ladder stent in accordance with theinvention, in an expanded condition;

FIG. 6 shows a strip used to form a serpentine coiled ladder stent inaccordance with the invention; and

FIG. 7 shows a serpentine coiled ladder stent in accordance with theinvention, in an unexpanded condition.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

FIG. 1 shows a schematic diagram of cross-sections through three priorart stents, each formed of a helically wound wire. The top coiled wirestent A is in its optimal, desired condition, with each of the windings1′ evenly spaced from the next. Thus, the gaps 2′ between the adjacentwindings 1′ are relatively uniform, such that a relatively uniformsupport is provided to the vessel wall, should the windings 1′ remainevenly spaced as shown.

In practice, though, a coiled wire stent as shown in FIG. 1 sometimestends to change configuration, particularly during and afterimplantation when it is subjected to various stresses in the vessel.Thus, some of the windings may tend to separate somewhat, as shown inthe middle coiled wire stent B in FIG. 1. In the middle coiled wirestent B, the windings 1″ are spaced unevenly, sometimes leavingsignificant gaps 2″.

Alternatively or additionally, the windings of the traditional coiledwire stent may bend or tilt while in the vessel. In the bottom coiledwire stent C in FIG. 1, some of the windings 1′″ have tilted somewhat.These tilted windings not only fail to provide proper support to thevessel, but they also enter and partially obstruct the passagewaythrough the stent, thus seriously compromising the lumen.

One way to overcome the instability problems of the coiled wire stent isto replace the wire with a ribbon having a width substantially largerthan its thickness. FIG. 2 shows an unexpanded coiled ribbon stent 10mounted on a catheter 15. As shown in FIG. 2, the coiled ribbon stent isformed as a helically wound ribbon strip. Because the width of theribbon in the coiled ribbon stent 10 as shown in FIG. 2 is greater thanthe width of the wire in the coiled wire stent A as shown in FIG. 1, thewindings 11 of the coiled ribbon stent 10 are relatively resistant tolongitudinal displacement or tilting.

FIG. 3 shows the coiled ribbon stent 10 of FIG. 2 in an expandedcondition. Expansion may be accomplished, for example, by inflating aballoon 16 on the catheter 15, with the outward force of the balloon 16acting on the inside of the stent 10 and causing the stent 10 to expand.When the coiled ribbon stent 10 is expanded as shown in FIG. 3, thediameter of the individual windings 11 increases. However, because thelength of the ribbon strip is constant, the increase in diameter causesthe ribbon strip to unwind somewhat, in order to accommodate theexpansion. In doing so, the ends 13 of the stent 10 rotate, the numberof windings 11 decreases, and the overall length of the stentforeshortens and/or gaps are formed between adjacent windings 11. Therotation of the stent, particularly of the stent ends, is potentiallyharmful to the vessel, and the decrease in windings and the decrease inlength of the stent or the opening of significant gaps between windingsresults in less of the vessel wall being supported and unpredictablelesion coverage.

In addition to these disadvantages, the coiled ribbon stent 10 is alsosomewhat disadvantageous in that the metal of the ribbon strip covers ahigh percentage of the surface area of the stented vessel wall. Thishigh percentage of metal coverage inhibits or slows down the healingresponse of the vessel wall to the trauma of stenting. This problem ofthe high percentage of metal coverage in the coiled ribbon stent 10 maybe solved by modifying the ribbon strip to a ladder strip, in which thestrip coiled to form the stent has a series of openings in it,resembling a ladder. FIG. 4 shows an example of a coiled ladder stent20, similar to the prior art coiled ladder stents shown and described inU.S. Pat. No. 4,553,545 to Maass et al.

In the coiled ladder stent 20, the strip has side bands 24, 25 bridgedby cross struts 26. The side bands 24, 25 and the cross struts 26 form aseries of openings 27, in which each opening 27 is bounded by the twoside bands 24, 25 and two cross struts 26. Similarly to the coiled wireand the ribbon strip, the ladder strip is wound helically, forming aseries of windings 21.

The coiled ladder stent 20 retains the rigidity and stability associatedwith the coiled ribbon stent 10, since the individual windings 21 of theladder strip, like the windings 11 of the ribbon strip, have increasedwidth as compared to the individual windings of the coiled wire. Inaddition, because of the openings 27, the coiled ladder stent 20 yieldsa reduced area of metal coverage as compared to the coiled ribbon stent10, without compromising support of the tissue.

The coiled ladder stent 20, however, still has some of the samedisadvantages associated with the coiled wire and ribbon stents. Mostsignificantly, the ladder strip unwinds somewhat upon expansion,resulting in twisting of the stent and rotation of the stent ends 23, aswell as foreshortening of the stent or the opening of significant gapsbetween adjacent windings.

FIG. 5 shows a serpentine coiled ladder stent 30 constructed inaccordance with the invention. The serpentine coiled ladder stent 30 inFIG. 5 is shown mounted on a catheter 15, in an expanded condition.

The serpentine coiled ladder stent 30 illustrated in FIG. 5 isconfigured as a coiled stent in which the coil is formed from a woundstrip of cells 37, wherein the sides of the cells 37 are serpentine.Thus, the stent is comprised of a strip helically wound into a series ofcoiled windings 31, wherein the strip is formed of two side bands 34, 35connected to each other, for example by a series of cross struts 36.Each side band 34, 35 is formed in a serpentine pattern comprising aseries of bends 38, wherein upon expansion of the stent, the bends 38 ofthe side bands 34, 35 open to increase the length of each of theindividual cells 37 in the helical direction, thereby lengthening thestrip in the helical direction to allow the stent 30 to expand withoutany significant unwinding of the strip. In this illustrated embodiment,the bends in the side bands 34, 35 occur in a periodic pattern. Thebends 38 may be arranged, for example, in the pattern of a sine wave, orin any other suitable configuration.

In the illustrated embodiment, the cross struts 36 joining the sidebands 34, 35 to each other are straight and extend in a directiongenerally perpendicular to the helical direction in which the strip iswound. Alternatively, the cross struts may have one or more bends,and/or they may extend between the two side bands at other angles. Inthe illustrated embodiment, the cross struts 36 join oppositely facingbends 38 on the side bands 34, 35, and they are attached to the sidebands 34, 35 at every second bend 38. Alternatively, the cross struts 36may be joined in other places, and may occur with more or lessfrequency, without departing from the general concept of the invention.The stent alternatively may be made without cross struts 36, by havingthe two serpentine side bands 34, 35 periodically joined to each otherat adjacent points.

As shown in FIG. 5, the ends 33 of the serpentine ladder strip may betapered. The tapering of the ends 33 of the strip allows the ends offinished stent to be straight, i.e., it allows the stent to take theform of a right cylinder, with each of the ends of the cylindrical stentlying in a plane perpendicular to the longitudinal axis of the stent.The ends 33 of the strip may be joined, for example by welds, torespective adjacent windings 31.

FIG. 6 shows a strip 40 used to form a serpentine coiled ladder stent inaccordance with the invention. The strip 40 has serpentine side bands44, 45, joined by cross struts 46. The strip 40 is tapered at its ends,such that the serpentine side bands 44, 45 25 converge at ends 43.

FIG. 7 shows a serpentine coiled ladder stent 50 in accordance with theinvention, in an unexpanded condition. As shown in FIG. 7, the taperedends 43 may be joined to the respective adjacent windings.

When the serpentine coiled ladder stent is expanded, as shown in FIG. 5,the outward radial force on the stent causes the bends 38 in theserpentine sides 34, 35 to open, thereby causing the length of the cells37 to increase in the helical direction. This feature of the expandablecells of the strip allows the overall length of the strip to increase inthe helical direction. By the strip itself lengthening in the helicaldirection as the stent is expanded, the increase in the diameter of thestent is accommodated without the need for the strip to unwind. In thismanner, the number of windings 31 is maintained, and rotation of theends 33 is avoided. In fact, because the ends 33 do not rotate, they maybe welded, as mentioned above, to the respective adjacent windings 31,thereby creating smooth ends. Other adjacent points on the stentwindings 31 may similarly be joined, to increase stability of the stentat the expense of flexibility.

A serpentine coiled ladder stent according to the invention retains theflexibility associated with coiled wire stents, but avoids some of theproblems associated with those stents. The windings of the serpentinecoiled ladder stent are relatively stable and insusceptible todisplacement or tilting, which has been associated not only withstraight single strand coiled stents as in the Maass '545 patent butalso with serpentine single strand coiled stents, such as in the Wiktor'062 and '732 patents and in the Cordis Crossflex stent. In addition, aserpentine coiled ladder stent according to the invention providescontinuous support of the vessel tissue without a disadvantageously highpercentage of metal coverage. Because the strip from which the stent ismade can expand in length in the helical direction, the strip canlengthen on expansion to accommodate the increased diameter, therebysubstantially avoiding the problems of end rotation and foreshorteningor the opening of significant gaps between windings upon expansion.

The strip for forming the serpentine coiled ladder stent may be made,for example, of wire or flat metal. When flat metal is used, the patternin the strip may be formed, for example, by laser cutting or chemicaletching. The stent may be manufactured by first manufacturing the strip,then winding the strip in a helix to form the stent, and then, ifdesired, welding the ends of the strip to the adjacent windings.Alternatively, the stent may be formed by forming the desired patterndirectly out of a tube, by laser cutting or chemical etching, or byforming the desired pattern out of a flat sheet, by laser cutting orchemical etching, and then rolling that flat sheet into a tube andjoining the edges, for example by welding. Any other suitablemanufacturing method known in the art may be employed for manufacturinga stent in accordance with the invention.

The embodiments described herein are examples only, as other variationsare within the scope of the invention as defined by the appended claims.

What is claimed is:
 1. A stent comprised of a strip helically wound intoa series of coiled windings, wherein the strip has at least two sidebands, wherein each of the at least two side bands is formed in aserpentine pattern comprising a series of bends, wherein the at leasttwo side bands of the strip are connected to each other, and whereinupon expansion of the stent, the bends of the at least two side bandsopen to lengthen the strip in the helical direction to allow the stentto expand without any significant unwinding of the strip, wherein thestrip has two ends, wherein the at least two side bands converge towardeach other at the two ends of the strip, so that the two ends of thestrip are tapered.
 2. A stent as claimed in claim 1, wherein the crossstruts connect adjacent bends on the at least two serpentine side bands.3. A stent as claimed in claim 2, wherein the adjacent bends that areconnected by each cross strut face in opposite directions.
 4. A stent asclaimed in claim 2, wherein the cross struts connect the at least twoserpentine side bands at periodic intervals, and wherein each of the atleast two serpentine side bands has at least one bend between sequentialcross struts.
 5. A stent as claimed in claim 2, wherein the cross strutsare straight.
 6. A stent as claimed in claim 1, wherein the at least twoserpentine side bands are connected to each other by cross struts andwherein the cross struts have bends.
 7. A stent as claimed in claim 2,wherein the cross struts extend generally perpendicularly to the helicaldirection in which the strip is wound.
 8. A stent as claimed in claim 1,wherein the strip has two ends, the first end of the strip being locatedat a first end of the stent and the second end of the strip beinglocated at a second end of the stent, and wherein each end of the stripis joined to an adjacent winding of the stent.
 9. A stent as claimed inclaim 8, wherein each end of the strip is joined to the adjacent windingby welding.
 10. A stent as claimed in claim 1, wherein the strip is madeof wire.
 11. A stent as claimed in claim 1, wherein the strip is madefrom flat metal.
 12. A stent as claimed in claim 1, wherein the stent ismade by manufacturing the strip and then winding the strip in a helix toform the stent.
 13. A stent as claimed in claim 1, wherein the two endsof said strip taper to the extent that the two side bands meet.
 14. Astent as claimed in claim 8 wherein the ends of said stent are smooth.15. A stent comprising: a strip having two ends helically wound into aseries of coiled windings, the strip including: at least two side bandswhich are spaced apart, each of the at least two side band being formedin a serpentine pattern comprising a series of bends, connectorsperiodically connecting the at least two side bands of the strip to eachother, and the at least two side bands converge toward each other at thetwo ends of the strip, so that the two ends of the strip are tapered tothe extent that the two side bands meet, and where in upon expansion ofthe stent, the bends of the at least two side bands open to lengthen thestrip in the helical direction to allow the stent to expand without anysignificant unwinding of the strip.
 16. A stent as claimed in claim 15,wherein a first end of the strip is located at a first end of the stentand a second end of the strip is located at a second end of the stent,and wherein each end of the s trip is joined to an adjacent winding ofthe stent.
 17. A stent as claimed in claim 16, wherein each end of thestrip is joined to the adjacent winding by welding.
 18. A stent asclaimed in claim 15, wherein the cross struts connect adjacent bends onthe at least two serpentine side bands.
 19. A stent as claimed in claim18, wherein the adjacent bend s that are connected by each cross strutface in opposite directions.
 20. A stent as claimed in claim 18, whereinthe cross struts connect the at least two serpentine side bands atperiodic intervals, and wherein each of the at least two serpentine sidebands has at least one bend between sequential cross struts.
 21. A stentas claimed in claim 18, wherein the cross struts are straight.
 22. Astent as claimed in claim 21, wherein the at least two serpentine sidebands are connected to each other by cross struts and wherein the crossstruts have bends.
 23. A stent as claimed in claim 18, wherein the crossstruts extend generally perpendicularly to the helical direction inwhich the strip is wound.
 24. A stent as claimed in claim 15, whereinthe strip is made of wire.
 25. A stent as claimed in claim 15, whereinthe strip is made from flat metal.
 26. A stent as claimed in claim 15,wherein the stent is made by manufacturing the strip and then windingthe strip in a helix to form the stent.
 27. A stent as claimed in claim16 wherein the ends of said stent are smooth.